Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
  • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
  • A61B8/445—Details of catheter construction
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
  • A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/54—Control of the diagnostic device
  • A61B8/546—Control of the diagnostic device involving monitoring or regulation of device temperature
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01K—MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR
  • G01K11/00—Measuring temperature based upon physical or chemical changes not covered by groups G01K3/00, G01K5/00, G01K7/00 or G01K9/00
  • G01K11/22—Measuring temperature based upon physical or chemical changes not covered by groups G01K3/00, G01K5/00, G01K7/00 or G01K9/00 using measurement of acoustic effects
  • G01K11/24—Measuring temperature based upon physical or chemical changes not covered by groups G01K3/00, G01K5/00, G01K7/00 or G01K9/00 using measurement of acoustic effects of the velocity of propagation of sound
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01K—MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR
  • G01K13/00—Thermometers specially adapted for specific purposes
  • G01K13/20—Clinical contact thermometers for use with humans or animals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/1206—Generators therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00636—Sensing and controlling the application of energy
  • A61B2018/00696—Controlled or regulated parameters
  • A61B2018/00702—Power or energy
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00636—Sensing and controlling the application of energy
  • A61B2018/00773—Sensed parameters
  • A61B2018/00791—Temperature
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
  • A61B90/37—Surgical systems with images on a monitor during operation
  • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
  • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
  • A61B8/0883—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of the heart
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy
  • A61N2007/0078—Ultrasound therapy with multiple treatment transducers
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01K—MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR
  • G01K2217/00—Temperature measurement using electric or magnetic components already present in the system to be measured

Definitions

• the invention relates to a medical ultrasound device, such as a probe or catheter-based device.
• a medical ultrasound device such as a probe or catheter-based device.
• the invention relates to such devices capable of detecting the temperature at the distal end of the device.
• cardiac arrhythmias may be treated by various catheter-based ablation techniques to destroy arrhythmogenic parts of the cardiac tissue.
• RF radio-frequency
• HIFU high intensity focused ultrasound
• cryo-ablations of the tissue are commonly used.
• the probe temperature reflects the tissue temperature.
• the ablation profile may be controlled by the temperature, and direct thermal feedback may be used to titrate the ablation energy.
• the US patent application no. 2006/0030844 Al discloses to use a transparent electrode suitable for radio frequency (RF) ablation of tissue. It is disclosed to cover a transparent material with a conductive coating so that the conductive coating is capable of delivering RF energy to the tissue, while the combined system of transparent material and coating is transparent to radiation from various imaging modalities. Different surface temperature means for measuring the temperature are disclosed. For example, it is disclosed to place a thermocouple on the electrode surface.
• RF radio frequency
• thermocouple on the electrode surface however puts the thermocouple in the field of view. While this may be acceptable for some application, this may not be the case for all applications. Moreover, there is still a need in the art for alternative or improved temperature sensing solutions, suitable for use in connection with catheter-based surgery.
• thermocouple-based temperature sensing solutions may not be suitable for use in connection with medical devices comprising integrated ultrasound monitoring in the forward looking geometry, since the positioning of the thermocouple may be in the field of view of the acoustic radiation.
• the invention preferably seeks to mitigate, alleviate or eliminate one or more of the above mentioned disadvantages singly or in any combination.
• a medical ultrasound device comprising:
• an elongated body having a proximal end, a distal end, a distal end region and a length axis along the elongation;
• one or more ultrasound transducers for generating acoustic radiation, the one or more ultrasound transducers being positioned in the distal end region, inside the elongated body;
• a transmission element positioned in the radiation path of the acoustic radiation, wherein the transmission element is substantially transparent to acoustic radiation
• controller unit operatively connected to the ultrasound transducer
• controller unit detects the acoustic path length through the transmission element and determines the temperature at the distal end from the detected acoustic path length.
• the invention provides a medical device, such as a catheter or probe, with integrated ultrasound facilities, where the ultrasound radiation can be used for general purposes, as well as for generating a measure of temperature of the transmission element. Since during use, the transmission element will be in close contact with tissue under investigation or treatment, this temperature will be the same as, or close to, the temperature of the tissue. By measuring the temperature of the transmission element, the temperature at the distal end of the medical ultrasound device, and hence the temperature of the tissue under investigation or treatment, can be determined.
• the one or more ultrasound transducers are capable of generating acoustic radiation suitable for monitoring a region of interest simultaneously with, concurrently with or together with detecting the acoustic path length through the transmission element.
• a temperature sensor may be provided which does not shadow the acoustic radiation.
• monitoring is to be construed broadly. It includes both ID monitoring, i.e. detecting reflected intensities along the line of sight as well as 2D imaging where an array of transducers are applied to generate a 2D image. In principle also 3D imaging and time resolved imaging may be obtained.
• ID monitoring i.e. detecting reflected intensities along the line of sight
• 2D imaging where an array of transducers are applied to generate a 2D image.
• 3D imaging and time resolved imaging may be obtained.
• catheter-based monitoring it is normal to use ID or 2D monitoring due to space constraints in the distal end region, i.e. in the tip region.
• the transmission element should be substantially transparent to acoustic radiation.
• a material with a transparency to acoustic radiation above 50% may be used, such as above 60%, 70%, 80%, 90%, or even above 95%.
• the acoustic path length is detected based on detecting reflected acoustic radiation from the transmission element.
• the acoustic path length is detected based on detecting reflected acoustic radiation from a surface of the backside of the transmission element and a surface of the front-side of the transmission element, the acoustic path length may be detected based on detecting a separation of reflection peaks obtained from the surface of the backside of the transmission element and the surface of the front-side of the transmission element.
• the detection of the acoustic path length may be based on a detection of the time of flight, and changes in time of flight, of radiation emitted from the transducer, reflected from a surface of the transmission element, and detected again by the transducer.
• the polymer-based body has a change of velocity of the acoustic radiation larger than 0.1 % per degree Celsius or larger, such as 0.25%> per degree Celsius or even larger.
• the distal end region further comprises fluid channels which allow delivery of fluid through the elongated body to the distal end region.
• saline fluid may be pumped from a reservoir placed at the proximal end to irrigate the area under investigation or treatment.
• the temperature at the distal end is determined based on a look-up table or a functional relationship between a parameter related to the acoustic path length and the temperature at the distal end.
• a look-up table or a functional relationship between a parameter related to the acoustic path length and the temperature at the distal end.
• the transmission element comprises a treatment modality for treatment of body tissue.
• the treatment modality is ablation, such as radio frequency (RF) ablation.
• RF radio frequency
• the ablation is performed by use of an electrode supported by the transmission element.
• the electrode may be provided such that the acoustic radiation is substantially unaffected by the presence of the electrode.
• the electrode is in the form of a thin layer sufficiently thin to be substantially transparent to acoustic radiation. Acoustic radiation will be transmitted substantially unaffected by the presence of a metal layer with a thickness below 500 nanometers, such as below 250 nanometers, such as with a thickness of 150 nanometers.
• the electrode may be in the form of a mesh or other open structures. An electrode in the form of a mesh, with a central aperture or even in the form of a band or ring, may allow radiation to pass, and still be able to work as an RF-electrode.
• a medical device in accordance with the first aspect of the invention is operated by steps which comprise:
• a computer program product is presented that is adapted to enable a computer system comprising at least one computer having data storage means associated therewith to operate a medical device according to according to the first aspects of the invention or to carry out the steps of the second aspect of the invention.
• FIG. 1 schematically illustrates the distal end region of an ablation catheter- based probe
• FIG. 2 schematically illustrates an ablation electrode supported by a transmission element
• FIG. 3 illustrates a screen shot of an M-mode ultrasound image of cardiac ablation in a sheep heart
• FIG. 4 illustrates a zoom made of the first order TPX/Pt reflection peak of the M-mode image of FIG. 3;
• FIG. 5 shows a graph of peak separation as a function of time
• FIG. 6 illustrates a graph correlating the peak separation, the speed of sound and the temperature
• FIG. 7 further illustrates peak separations as a function of temperature
• FIG. 8 illustrates a flow diagram of steps performed in connection operating a medical device
• FIG. 9 schematically illustrates a medical device connected to a controller unit and in connection with a computer program product.
• the present invention is disclosed in connection with a RF ablation catheter comprising a monitoring system in accordance with embodiments of the present invention. It is however to be understood that, while such an application is advantageous, the invention is not limited to this. In fact, the medical device may be applied in connection with any device which uses ultrasound transducers and which supports a structural configuration which enables to detect an acoustic path length through a transmission element.
• FIG. 1 schematically illustrates the distal end region 1 of an ablation catheter- based probe, hereafter also simply referred to as a catheter.
• the catheter comprises an elongated body 3, a proximal end (not shown), a distal end 10 and a distal end region 1.
• a length axis 9 runs along the elongation of the elongated body.
• the distal end region 1 is the extended end section of the elongated body 3 abutting the distal end itself 10.
• the catheter may at the proximal end comprise a controller unit or connection for a controller unit (cf. FIG. 9).
• the ultrasound transducer 4 is housed in the distal end region, where it is fixed by suitable means 6.
• the catheter comprises a transmission element 5 positioned in the radiation path of the acoustic radiation.
• the transmission element may be used as a transmission window for coupling the acoustic radiation out of the medical device.
• the transmission element has a backside generally facing the ultrasound transducer and an opposite facing front-side.
• the transmission element is substantially transparent to acoustic radiation, so that radiation generated by the ultrasound transducer will be transmitted through the transmission element to interact with tissue 2 under investigation or treatment.
• the acoustic radiation is emitted along the length axis 9.
• the distal end region may further comprise fluid channels 7 which allow delivery of fluid through the elongated body to the distal end region so as to irrigate the treatment site during treatment if this is necessary or desirable, typically by use of saline fluid.
• the fluid channels may be holes into the side of the tube as in the illustrated embodiment, or made by other suitable means.
• the device may e.g. be an ultrasound catheter with an integrated ablation electrode.
• the ultrasound catheter supports monitoring of tissue properties by operating the ultrasound transducer in a monitoring mode, where ultrasound pulses are emitted and the reflected radiation is detected in order to generate an ultrasound image or scan.
• Operating an ultrasound transducer for detecting reflected radiation is known to the skilled person.
• the elongated body may be of a flexible material, such as a suitable polymer material for use in connection with a medical device. Such materials are known to the skilled person. A flexible device is thereby obtained. Alternatively may the elongated body be made of a rigid material, such as surgical steel or other suitable materials as are known to the skilled person. A rigid device may e.g. be implemented as a needle device.
• FIG. 2 schematically illustrates an ablation electrode 20 supported by a transmission element 5.
• the transmission element has a backside 21 and a front side 22.
• the ablation electrode may be formed by a thin conducting layer supported by the transmission element.
• the transmission element comprises a polymer-based body and a conducting layer.
• the polymer-based body may be of the material poly-methylpentene (TPX) which is commonly used in connection with ultrasound, whereas the conducting layer may be a metallic layer, such as a platinum layer. Suitable thicknesses may be a few hundred micrometers thick TPX supporting a few hundred nanometer thick platinum layer, such as a 250 micrometer thick TPX element, supporting a 150 nanometer thick platinum layer. The thickness of the TPX element is the thickness at the central region. Other materials may also be used, as long as they are sufficiently transparent to acoustic radiation.
• the transmission element and supported electrode are illustrated in a rounded configuration which is the clinically relevant shape. In general any shape may be used.
• FIG. 3 illustrates a screen shot of an M-mode ultrasound image of cardiac ablation in a sheep heart as generated by an ablation catheter of the type schematically illustrated in FIG. 1.
• the vertical axis shows the distance from the transducer. The distance is given in pixels which can be converted into time or depth.
• the horizontal axis illustrates time, again given in pixels (increments of 20 pixels equals 1 second).
• the image shows the strong primary reflection 30 from the TPX/Pt ablation electrode, and in addition 2nd and 3rd order reflection peaks 31, 32.
• FIG. 4 illustrates a zoom made of the first TPX/Pt reflection peak 30, as indicated with reference numeral 33 on FIG. 3.
• the two peaks (maxima indicated by reference numerals 40, 41) are observed.
• the positions of these reflections are related to the time-of- flight of the ultrasound signal, and therefore the acoustic path length through the transmission element.
• the maxima of the two peaks are observed to be relatively constant with respect to time in the first half of the image, however as can be seen during the period indicated with reference numeral 42 where the ablation process is running, the distance 43, 44 between the two peaks increases.
• the first peak 40 corresponds to the transition of the acoustic radiation into the transmission element
• the second peak 41 corresponds to the transition of the acoustic radiation out of the transmission element. In the area between the two peaks, the ultrasound radiation is propagating inside the
• the acoustical path length through the transparent ablation electrode increases too.
• the acoustic path length can be monitored. From analysis of the monitored data, it is possible to obtain sub-pixel resolution.
• the main physical effect which gives rise to the changes in the acoustical path length is the change of the speed of sound in dependence upon the
• FIG. 5 shows a graph of the peak separation 43, 44 as a function of time in the ablation period as indicated with reference numeral 42 in FIG. 4.
• the vertical axis is peak separation in pixels and the horizontal axis is time in seconds.
• the graph shows measuring points 50 as well as a calculated line 51 of the expected thermal effect. The calculation was obtained by assuming 4 mm thick cardiac tissue, cold surfaces and a 6 mm diameter ablation catheter.
• the vertical axis includes only a single fitting parameter in the form of the product of the ablation power and thermal conductivity.
• the horizontal axis does not contain fitting parameters.
• FIG. 6 illustrates a graph correlating the peak separation (left vertical axis), the speed of sound (right vertical axis) and the temperature in degree Celsius (horizontal axis).
• the measurement points are shown as solid bullets 60 (a line is drawn through the points to guide the eye), moreover, a line 61 is shown indicating 0.25% expansion per °C of the acoustic path length for comparison to the data.
• the catheter is capable of accurately determining the temperature at the location of the point of contact between the ablation electrode and the tissue, which is the clinically interesting point.
• FIG. 7 further illustrates peak separations as a function of temperature.
• FIG. 7 illustrates a laboratory experiment, where the acoustical path length between the two peaks was measured for a medical device with the distal end region submerged in a water bath for a series of constant temperatures.
• a line 70 is shown which indicate 0.25% expansion per °C of the acoustic path length for comparison to the data.
• Point connected by the line with reference numeral 71 connect data points obtained during temperature rise 72, whereas point connected by the line with reference numeral 73 connect data points obtained during temperature decent 74.
• thermal resolution is of the order of 1 °C within the range of clinical relevant temperatures.
• the temperature at the distal end may be determined based on a look-up table or a functional relationship between a parameter related to the acoustic path length and the temperature at the distal end, e.g. as deduced from a measurement as presented in FIG. 7.
• Look-up table, functional relationships etc. may be stored by and computed in the controller unit or a computing unit in or connected to the controller unit.
• FIG. 8 illustrates a flow diagram of some of the steps which may be performed in order to operate a medical device in accordance with embodiments of the present invention.
• the medical device may be positioned 80 in the region of interest, for example in close proximity of cardiac tissue to undergo ablation treatment.
• the transducers are operated to generate 81 acoustic radiation and to detect 82 the reflected acoustic radiation.
• the transducers may be operated continuously 83 during the investigation and treatment.
• the reflected acoustic radiation is detected in order to monitor 84 the region of interest during the procedure, and from the reflected acoustic radiation also the acoustic path length is deduced to determine the temperature 85 at the distal end.
• the treatment modality may be operated 86 in order to perform medical treatment.
• the tissue under treatment may undergo ablation.
• FIG. 9 schematically illustrates a medical device connected to a controller unit and in connection with a computer program product.
• the medical device comprises a catheter in accordance with embodiments of the present invention.
• the catheter comprises an elongated body 3 having a proximal end 90, a distal end 10, a distal end region 1 and a length axis 9 along the elongation.
• the catheter comprises one or more ultrasound transducers positioned in the distal end region and a transmission element 5 positioned at the extremity of the elongated body to couple acoustic radiation in and out of the catheter.
• the catheter is at the proximal end 90 connected to a controller unit 91, such as a dedicated purpose or general purpose computing unit for control of at least the ultrasound transducer(s) and for dealing with the signal treatment and extraction of detection results.
• a controller unit 91 such as a dedicated purpose or general purpose computing unit for control of at least the ultrasound transducer(s) and for dealing with the signal treatment and extraction of detection results.
• the detection of the acoustic path length through the transmission element and the determination of the temperature at the distal end are controlled by the controller unit 91.
• the controller unit may implement a computer system 92, such as a dedicated purpose or general purpose computing unit for controlling the device.
• the computer system may comprise storage means 93 for storing data which may be needed to operate the medical device or to store any acquired data, or for any other purpose where storage of data is desired.
• the computer system may be adapted to receive instructions from a computer program product 94 in order to operate the device.
• the computer program product may be comprised in a data carrier as illustrated in the Figure, however once loaded into the computer system it may be stored by, and run from, the storage means 93.

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• 2010
  • 2010-09-15 JP JP2012529386A patent/JP6270315B2/ja not_active Expired - Fee Related
  • 2010-09-15 RU RU2012115115/14A patent/RU2549528C2/ru active
  • 2010-09-15 EP EP16182768.8A patent/EP3117776B1/de active Active
  • 2010-09-15 US US13/393,857 patent/US10743836B2/en active Active
  • 2010-09-15 CN CN201080041298.0A patent/CN102497822B/zh active Active
  • 2010-09-15 WO PCT/IB2010/054153 patent/WO2011033454A1/en active Application Filing
  • 2010-09-15 BR BR112012005696A patent/BR112012005696A8/pt not_active IP Right Cessation
  • 2010-09-15 EP EP10760774A patent/EP2477553A1/de not_active Withdrawn
• 2020
  • 2020-08-18 US US16/996,466 patent/US11497464B2/en active Active

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